FDA-Drug2026-04-15Class IIPROCESSING DEFECT
Fresenius Kabi sodium chloride injection recalled for sterility assurance issue
OTHERNationwide distribution
Do not use Fresenius Kabi saline injection
Fresenius Kabi USA is recalling specific batches of 0.9% Sodium Chloride Injection (a sterile saline solution) because the manufacturer cannot guarantee the product is free from contamination. The affected batches were distributed nationwide, including Alaska and Puerto Rico, between now and June 2027.
- Check if you have any of the affected batch numbers (6402153, 6402297, 6402298, 6402377, 6402378, 6402379, 6402429, 6402430, 6402431, 6402432, 6402433, 6402434, 6402512, 6402574, or 6402576)
- Do not use the product if you have an affected batch
- Contact your pharmacy, hospital, or healthcare provider if you have received this product
- Speak with your doctor or pharmacist about a safe replacement
Hazard
Lack of Assurance of Sterility
Sold states
US Nationwide , Alaska, and Puerto Rico.
Manufactured in
3 Corporate Dr, Lake Zurich, IL, United States
Products
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0430-2026More Fresenius Kabi USA, LLC recalls
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility concerns
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
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